MINI TREK™ 1012403-12ARecalls & reported problems
Abbott Vascular Inc. · MINI TREK™ II Coronary Dilatation Catheter 2.00 mm x 12 mm / Over-The-Wire · Class 2
All models of MINI TREK (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648180873), received between May 3, 2024 and Mar 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATION, THE 2X12MM MINI TREK II BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM); THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH A TREK BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24645697 ↗MalfunctionMay 3, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE 2.0X12MM OTW MINI TREK BALLOON DILATATION CATHETER (BDC) WAS DEFECTIVE PRIOR TO USE. THE BALLOON WAS INFLATED TO 4 ATMOSPHERES WHEN IT WAS NOTED THE BALLOON HAD RUPTURED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237986 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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